Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -360

Accepted - Volume 6

Comment Record
Commentor Mr. Thomas Evans Date/Time 2002-09-07 00:19:37
Organization Mr. Thomas Evans
Category Individual

Comments for FDA General
Questions
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? The public's health takes presidence over the corporations right to commercial speech. It is the FDA's duty to protect the public from commercial speech that may harm it. Commercial speech is for promoting a product and so developing a profit, any educational benifits are subsumed into this motive.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? Direct to consumer ads are designed to circumvent the wisdom of the physician by convincing a pateint of the need for a certain drug. By definition the ads must give a distorted veiw of the drugs worth.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? The time and focus spent on the desirability of a product should be spent on the negative side. That is if a half page shows a woman enjoying life because of hormone replacement, a half page should graphically illustrate the effects of breast cancer as a side effect




EC -360